OncoMatch/Clinical Trials/NCT07172958
Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
Is NCT07172958 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells for rhabdomyosarcoma.
Treatment: Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells — This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME Tumor Antigen-specific T cells) following lymphodepleting chemotherapy in participants with relapsed/refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma and Wilms tumor. Patients will be enrolled to one of three planned dose levels with B7-H3 CAR T cell dose determined based on the percentage of B7-H3 transduced cells (B7-H3+ population of cells), and dTBRII-transduced PRAME TA-specific T cell dose based on the total cell population. Both doses will be based on the recipient's body weight and combined in a 1:1 ratio. The safety of the CAR-TA T cell product will be evaluated and the maximum tolerated dose (MTD) will be determined. The safety endpoint will be assessed by monitoring for dose limiting toxicities for 28 days following CAR-TA T cell administration.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Rhabdomyosarcoma
Sarcoma
Neuroblastoma
Demographics
Prior therapy
Must have received: standard of care therapy — for their specific tumor type
Refractory disease, residual detectable disease or relapsed disease following available standard of care therapies with known clinical benefit for their specific tumor type, or unable to receive such therapies due to unacceptable toxicity or contraindication
Cannot have received: allogeneic stem cell transplant
Patients who have undergone previous allogeneic stem cell transplant
Lab requirements
Blood counts
ANC > 500/µL (procurement), > 750/µL (infusion); ALC > 1000/µL (procurement); Platelet count > 50,000/uL (procurement), > 75,000/uL (infusion)
Kidney function
Serum creatinine within age/sex limits or creatinine clearance/GFR ≥ 70 mL/min/1.73 m²
Liver function
Bilirubin ≤ 2.5 mg/dL; AST/ALT ≤ 5x the upper limit of normal for age
Cardiac function
Shortening fraction ≥ 27% by echocardiogram, or ejection fraction > 50% by echocardiogram or radionuclide angiogram
Bilirubin ≤ 2.5 mg/dL; AST/ALT ≤ 5x the upper limit of normal for age; Serum creatinine within age/sex limits or creatinine clearance/GFR ≥ 70 mL/min/1.73 m²; ANC > 500/µL (procurement), > 750/µL (infusion); ALC > 1000/µL (procurement); Platelet count > 50,000/uL (procurement), > 75,000/uL (infusion); Shortening fraction ≥ 27% by echocardiogram, or ejection fraction > 50% by echocardiogram or radionuclide angiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's National Hospital · Washington D.C., District of Columbia
- Childrens National Hospital · Washington D.C., District of Columbia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07172958 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic stem cell transplant disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 23 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages